Today 5th September, the leaders of the main political group in the European Parliament, (a group known as the Conference of Presidents) will meet to decide on the timing of debate and vote on the tobacco products directive. The proposed text for debate, amendment and vote was only published on Friday 30 Aug and not in most languages. The deadline for amendments was on Wednesday 4th Sept. On current timetable, the debate and vote would be on 9th and 10th, we think this is a ridiculous reckless rush for something so complex, so poorly understood (not least by its main supporters) and but with so many lives at stake. It needs MEPs to have time to consider properly. A delay to October is reasonable, feasible and necessary.

As public health experts, we urge you to delay the debate and vote on the Tobacco Products Directive and hold it in October. We applaud members of the EPP, ALDE and ECR groups for already having declared their intention of doing so and hope that the Conference of Presidents will see fit to do the same.

The Directive is complex and far reaching, but is likely in its current form to obstruct the progress of an important new class of products, e-cigarettes, by misclassifying them as medicines. Goldman Sachs describes e-cigarettes as one of eight globally disruptive technologies. Some analysts see e-cigarettes overtaking cigarettes with a decade. The impact of that on public health will vastly overshadow all other measures in the directive, and it is critical that we get the regulatory regime right – thousands of lives are at stake. Taking an extra few weeks to do this properly is a sound investment in the lives of millions of Europeans.

The likely effect of the directive in its current form is to take the vast majority of the products off the market, to cause users to revert to smoking, to close hundreds of sound small businesses and to provide regulatory protection to pharmaceutical and tobacco companies. It is clear from debates and public statements that Members still have little awareness of what medicines regulation would mean for the e-cigarette market. Further concerns arise from dissent in the opinion committees – for example Legal Affairs found no acceptable legal base for this regulation. Further afield, there are four cases in which medicines regulation has been struck down by the courts in member states. The Commission has failed to consult properly on its proposal and the Impact Assessment is far from an adequate account of the impacts. For all these reasons we urge you to give Members more time to understand this critical technology and the regulatory options.

It has been widely reported that it is the major tobacco firms that want a delay. We have no brief for them or any interest in their objectives. But many public health experts, consumers and small businesses also want a delay so the directive can be scrutinised and revised carefully. A legislature should conduct its business with great care and transparency, and it should not matter whether tobacco companies agree or disagree with its chosen timetable.

We think it is essential that Members have adequate time to understand and scrutinise these proposals thoroughly, and we therefore urge you to support holding the debate and vote on this important directive in October.

Yours sincerely

Professor Gerry Stimson
Emeritus Chair at Imperial College London and Visiting Professor at the London School of Hygiene and Tropical Medicine.Clive Bates
Former Director of Action on Smoking and Health (1997-2003) and former senior civil servant (2003-12). Director Counterfactual Consulting and AdvocacyKonstantinos Farsalinos, M.D.
Researcher, Onassis Cardiac Surgery Center, Athens Greece; Researcher, University Hospital Gathuisberg, Leuven, BelgiumJacques Le Houezec
Consultant in Public Health and Tobacco dependence. He is a special Lecturer at the Department of Epidemiology & Public Health of the University of Nottingham in the UK. He was an expert of the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCHENIR): working group on smokeless tobacco products (2006-2008).

Their tactics are similar to a torturer – keep turning the screw and eventually all will break.One of the problems is that many of them see smoking as a lifestyle choice(reiterated in the Wales Online story today).This may be true for the light,social and occasional smokers – but these are the smokers that have already crumbled – the hard core ones will take a lot more.

There was a story in the Irish Times recently quoting examples of smokers going hungry rather than quit.The remaining smokers are those most addicted – the ones who will respond to the offer of an alternative means of smoking.We need our politicians to protect us from the torturers.

I think the NGO lobby has all the smugness of a group that feels like it is already winning. Cigarette volumes are in terminal decline (admittedly a slow decline). I think there is mentality that “we know how to beat this menace with our bag of tools (taxes, health warnings, health education, plain packaging, no flavors and so on).”

Once you think you are winning, you don’t want to change the terms of the game.

I keep seeing this fantasy that the pharmaceutical lobby is controlling tobacco regulation. Nicotine replacement therapy (NRT) is a pretty small market and is downright tiny compared to tobacco. I don’t doubt — I know — that NRT companies are cheering on harsh regulation but they are not controlling the agenda, imho. Rather, look to WHO and the various anti-tobacco NGO’s — they are your adversaries here.

I agree with ASD on this. The prime movers are the anti-tobacco NGOs and WHO, and they have captured critical governments. The best way to see this is that these groups are steeped in a ‘controlling’ mindset – in which the job is to apply restrictions, prohibitions and disincentives to the extent possible – driven by Manichean certainties about the tobacco industry. Every new new product is seen a threat to be contained and controlled. Actually, the public health objective is much better served by an ‘enabling’ approach to low risk products like e-cigs, snus or heat not burn tobacco products. But this is completely counter-cultural, so every imaginable proxy argument is thrown at these products: gateways, dual use, reduced quitting, impossible evidential hurdles, medicines designation.

Thank you for clarification Clive. It is so frustrating that, for the first time, there is a viable alternative to the death and disease caused by smoking and we have to fight the powers that be to allow us to use it. I hold no brief for the tobacco industry but if we vapers have forced them to invest in Harm Reduction products then that is no bad thing. The financial losers in all this are the Pharmaceuticals and those who benefit from their funding – they will fight us with whatever it takes – that was made amply clear on the eve of the ENVI meeting when social media was saturated with anti propaganda by WHO et al so be prepared. We appear to have put a spoke in McAvan’s wheel for the moment but continued dialogue with MEPs and MPs is vital. Westminster will be no easy ride if Labour remain entrenched. My thanks again for your invaluable input – it makes all the difference!

And now Linda complains that the timeline was know since January.Is she serious?
I don’t know exactly when it was changed, but I’m pretty sure the “Forecast” in the procedural file said 08/10 for a looooong time (at least ’til June …).

And what is her main concern?“The tobacco industry wants more time for lobbying”

Any MEP should feel insulted by this statement.

Those (few) that are susceptible to this kind of coercion, because they surely have already secured their secret nest egg.

And the vast majority of upright politicians because she insinuates that they are too gullible, weak, spineless or stupid to resist the lure of filthy lucre.

No, Ms. McAvan!
They just need the time to tell facts from fiction and fatal fantasy.

Yes any MEP can try to amend the agenda with a motion at the start of the meeting… It’s really to get small but important and urgent things on, not to override the business management of the political groups. MEPs I’ve spoken to say it is unlikely to succeed.

Rule 140 : Adopting and amending the agenda
1. At the beginning of each part-session, Parliament shall take a decision on the final draft agenda. Amendments may be proposed by a committee, a political group or at least 40 Members. Any such proposals must be received by the President at least one hour before the opening of the part-session. The President may give the floor to the mover, one speaker in favour and one speaker against, in each case for not more than one minute.

2. Once adopted, the agenda may not be amended, except in pursuance of Rules 142 or 174 to 178 or on a proposal from the President.

If a procedural motion to amend the agenda is rejected, it may not be tabled again during the same part-session.

3. Before closing the sitting, the President shall announce the date, time and agenda of the next sitting.

There is a discussion on UK Vapers about McAvan, whilst accepting on her blog that there will be a postponement, using a rule 140, which requires only 40 signatures, to stop the postponement. Do you know what this about, Clive?

[…] Strasbourg, France. It was important that the date was put back from September to October. We wrote to the Conference of Presidents to explain why. There is a chance that the rapportuer will try to add it to the agenda at the last […]

Chris – yes, basically. Main reasons:
1. Time to develop workable amendments – which people affected can look at and give comments on. It nearly all went wrong when one word in error was added to an amendment that would have applied the whole tobacco directive to e-cigs – ban on flavours, internet sales, track and trace regime etc That won’t happen given time. The report was published Friday 30th Aug, amendments were due 12.00 Wed 4th Sept.

2. Time to win hearts and minds and make the case – a rushed timetable favours the status quo, which in the case of this plenary would be medicines regs. As time goes on, we are reaching more and more MEPs – but while it was still with ENVI and over the summer, you it’s hard to get the attention of others so easily. The arguments are strong but they need to be heard, challenged and understood and they will percolate through. All takes time.

3. There is the genuine case to have a good legislative procedure that allows time and papers in national languages sufficient to make good laws. Hasty law-making creates bad law – and there’s more than enough of that already.

When I did read the amendment as officially published on the EU-site I realy had the impression the whole TPD apllied to e-cigs. “Nicotine-containing products may only be placed on the market in accordance with the provisions for tobacco products as laid out in this Directive.” Should this not be “… in this Article”?

One more further comment: “Nicotine-containing products may not be placed on the market unless Member States have appropriate regulation on advertising and promotion including a provision that excludes advertising and promotion for people below the age of 18.” What should vapers do between the time the TPD becomes effective and the time such a regulation is put in place; which may well be when pigs can fly since it is not mandatory for member states and it is left to their discretion to put such a regulation in place. A back door left wide open to the de facto ban?

You are right about this – well spotted. It was the outcome of a deal, but i don’t think any if those doing the deal wanted the effect this would have – unintentional drafting error I think rather than a devious plan. The people behind it are strong supporters and are trying to strike a balance between many different views aiming to get a majority. We were in real trouble with this on Weds as it would have been impossible to support. It’s another reason for a delay – so that amendments can be worked out properly and discussed ith those affected by them. Hopefully with the extra time we can get back in track.

I’m not questioning the MEP’s who did put this together in an extreme rush job. But I seriously question the intentions of the council and thus governments who will have to put the directive into action and will search with a fine comb for any loophole they can find to turn it around their way.

Clive one more remark: in 18.4 there is reference to the provisions set out in article 10 regarding the health warnings. Most of article 10 makes no sense at all to e-cigs; only paragraph 4 does, so why not state so to avoid confusion and misinterpretation?

You are right about that too and we pointed it out to the MEPs involved on Weds. This had previously been specific to article 10.4 which relates to the design of the warnings. Still excessive and negative in my view – why try to scare smokers away by having similar looking warnings? I’m just glad MEPs have chance to specify new amends before 8 Oct.

Even if these had gone down in unworkable form it would have been possible to fix them later in the ‘triologue’ process – the negotiation between Parliament, Council and Commission before the Council first reading, likely in December. The problem is that it harder to get MEPs to agree to support an amendment if it has self-evident flaws. (I realise that might surprise some!).

Thanks for the clarification. Regarding those warnings I disagree. The e-cig is aimed to smokers, and frankly those horror pictures and warnings have only a very marginal effect on a long-time smoker. On a non-smoker however and especially the youth it does make a huge impact not to start. But isn’t this exacltly what we want: give smokers an option and the free choice to do so without instigating others to start? Just my 2 cents.

A practical disadvantage however is that one single tiny prefilled cartridge would have to be boxed in a shoebox-size packaging in order to put all these warnings twice (back and front) on them in a country like Belgium were it has to be printed in 3 different languages. That will produce a lot of waste packaging and is not very ecological. But maybe the shops could start a shoebox recycling scheme to overcome this frontal attack on Mother Nature. Or may I suggest a provision is made in art 18 that all the info and warnings that need to be provided may be printed on an accompanying folded leaflet as well as on the product packaging whatever is more practical. That would reduce the carbon footprint considerably of the euro-health-sticker-obsession. ;)